Process Development Engineer - NPD/NPI
Location: Irvine, CA Los Angeles, United States
Experience: 4-6 Years of Experience
Job Summary:
We are seeking a highly motivated Process Development Engineer to support New Product Development (NPD) and New Product Introduction (NPI) projects within a regulated medical device manufacturing environment. The successful candidate will be responsible for end-to-end process design, characterization, equipment and product validation, and implementation of Good Manufacturing Practices (GMP) and documentation standards. This role will work cross-functionally with engineering, quality, manufacturing, and regulatory teams to ensure compliance and drive continuous improvement initiatives
Key Responsibilities:
- Lead process development activities for new product introduction, including process design, scale-up, and technology transfer.
- Plan and execute Process Validation (IQ/OQ/PQ) and Equipment Qualification in compliance with FDA, GMP, and ISO 13485 regulations.
- Conduct Design of Experiments (DOE), Statistical Process Control (SPC), and process capability analysis to support robust process development and root cause investigations.
- Collaborate with R&D, Quality, and Manufacturing teams to ensure design and process requirements are met throughout the product lifecycle.
- Author and maintain technical documentation, including process flow diagrams, validation protocols, risk assessments, and reports.
- Utilize PLM tools (preferably Windchill) for document control, change management, and project tracking.
- Support the development and optimization of standard operating procedures (SOPs), work instructions, and training documents.
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies to improve yield, reduce cost, and enhance quality.
- Communicate project updates, risk mitigation strategies, and validation outcomes to cross-functional stakeholders and leadership.
Required Qualifications:
- Bachelor's Degree in Engineering, Life Sciences, or a related technical field.
- 4-6 years of experience in process or manufacturing engineering within the medical device or regulated industry.
- Proven expertise in NPI/NPD, process characterization, and validation.
- Working knowledge of GMP, ISO 13485, and FDA regulatory requirements.
- Hands-on experience with validation and statistical tools such as Minitab, FMEA, SPC, and Gage R&R
Preferred Skills:
- Experience working with PLM systems, preferably Windchill.
- Familiarity with standard costing and cost reduction techniques.
- Ability to independently analyze data and develop process improvement strategies.
- Proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook).
- Excellent interpersonal, communication, and organizational skills.